PARAMAX TOTAL PROTEIN REAGENT TP— 510(k) K845052

Substantially Equivalent

American Dade

FDA 510(k) clearance K845052 for PARAMAX TOTAL PROTEIN REAGENT TP, Substantially Equivalent on 1984-04-13. Applicant: American Dade. Device class: 2.

Clearance details

Applicant: American Dade
Product code: Code CEK
Device class: Class 2
Regulation: 21 CFR 862.1635
Advisory panel: Clinical Chemistry
Date received: 1984-02-15
Decision date: 1984-04-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CEK

K992846 — HICHEM TOTAL PROTEIN REAGENT1999-10-18
K973108 — TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-501998-03-02
K980042 — CARESIDE TOTAL PROTEIN1998-02-04
K971524 — TOTAL PROTEIN OR TP1997-05-16
K961864 — CSF/URINE TOTAL PROTEIN1996-10-24

More clearances from American Dade

K873051 — STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAY1987-10-20
K873171 — STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY1987-09-29
K873052 — STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAY1987-09-14
K872789 — PARAMAX URINE/CSF CALIBRATOR1987-09-02
K872195 — DATA-FI DIMERTEST LATEX ASSAY1987-08-06

Data sourced from openFDA. This site is unofficial and independent of the FDA.